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Assessment of Needle-free Disposable-syringe Jet Injector (DSJI) ID Dose-sparing of Pandemic A H1N1 Influenza Vaccine

NCT01582633 · Status: UNKNOWN · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 300

Last updated 2012-06-21

No results posted yet for this study

Summary

This study will evaluate the immunological response and the safety profiles of seasonal, inactivated vaccine which contains in its composition the A/California/7/2009 H1N1 "pandemic" influenza virus, delivered via ID in reduced dose (0,1 mL) and (0,2 mL), and via IM in full dose (0,5 mL) delivered with needle-free, disposable-syringe jet injector, and control group with via IM in full dose (0,5 mL) delivered syringes and needles in subjects from 42 to 60 years old.

Reduced doses into the skin will be delivered by an investigational intradermal model of a licensed, needle-free, disposable-syringe jet injector (DSJI) system, LECTRAJET® M3 RA manufactured by D'Antonio Consultants International, Inc. DSJIs avoid the drawbacks and dangers of conventional needle-syringe injection. Delivery by DSJI into the skin is also rapid and simple and overcomes the difficulty and patient discomfort of the traditional Mantoux needle method for skin injection, as used for BCG vaccination and tuberculosis skin testing.

Participants will be assessed for local and systemic adverse events by clinical observation immediately after injection and then upon return on day 21 after each injection. In addition, investigators will call participants by telephone on days 2 and 7 days to collect information local and systemic side effects.

Serum will be collected on day 21 after each injection, and assayed for hemagglutination inhibition (HAI) using conventional methods performed by the Virology Lab of the Instituto de Medicina Tropical de São Paulo, blinded to the study arm allocations of each participant. Information about the adverse events would be collected on days 1, 3 and 7 after dose delivery. The investigators assessing adverse reactions will be blinded to the study arm to which each subject was allocated.

The primary endpoint of the study is to evaluate the vaccine's immunogenicity by HAI, each dose in accordance with international parameters which include: seroconversion or significant title increase (SCR), the frequencies by study arm of seroprotection defined as a post-vaccination titer of \>40 (1/dil) (SPR), as well as the Geometric Mean Titers (GMTRs) of post-vaccination sera.

Conditions

Interventions

BIOLOGICAL

2012 trivalent influenza vaccine

2012 trivalent influenza vaccine: * influenza A/California/7/2009 (H1N1) * influenza A/Perth/16/2009 (H3N2) * influenza B/Brisbane/60/2008 Single dose.

Sponsors & Collaborators

  • D'Antonio Consultants International, Inc.

    collaborator OTHER

  • Sao Paulo, Secretaria de Estado da Saúde

    collaborator UNKNOWN

  • University of Sao Paulo General Hospital

    lead OTHER

Principal Investigators

  • Glacus Brito, MD · Hosp das Clinicas da Faculdade de Medicina da Universidade de Sao Paulo

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
42 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2012-07-31
Primary Completion
2012-08-31
Completion
2012-09-30

Countries

  • Brazil

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01582633 on ClinicalTrials.gov